The Food and Drug Administration’s top vaccine official has overruled agency reviewers on three decisions involving COVID-19 vaccines, including the recent approval of Moderna’s shot for some young children, according to documents released by the FDA.
Dr. Vinay Prasad, the agency’s chief medical officer and head of its Center for Biologics Evaluation and Research, said in a memorandum dated July 9 and uploaded to the FDA’s website on July 11 that his analysis of Moderna’s Spikevax reached a different conclusion than that of agency reviewers.